Clinical Scientist

As a key member of the Clinical Study Team, the Clinical Scientist will work on one of Elicio’s vaccine or immunomodulator programs in close collaboration with the study medical monitor, to provide scientific guidance and cross functional support to the team. In this role, the incumbent will be responsible for various aspects of clinical study execution including data cleaning/trend analysis, query generation, medical coding review, development of case report forms and edit checks, protocol development, investigator interactions, staff and investigator training, and will be expected to identify gaps and drive solutions to support dose escalation, independent data monitoring committee, interim analyses and regulatory filings in regards to data quality. This position involves collaborative cross functional teamwork with a positive attitude and may be office based in the Seaport area of Boston, Massachusetts. Fully remote can be considered for the right candidate with the expectation of periodic travel for in person team interactions. This position requires proficiency in Good Clinical Practices (GCP), Good Laboratory Practices (GLP) and relevant regulations. The successful candidate will drive, promote, and embed a culture of ethics, integrity and continuous improvement that will create a culture of inclusion, development, growth and retention of talent and empowerment of teams to achieve key milestones. Elicio (ELTX) is a growing organization based out of the Seaport area of Boston, Massachusetts with additional staff functioning in a virtual based environment from the Greater Boston area and throughout the United States. Major Duties/Responsibilities

Collaborates with the study medical monitor for data cleaning including query generation, medical coding review, pharmacovigilance, SAE review and reconciliation, in preparation for dose escalation, IDMC or data cutoffs to support interim analyses and regulatory filings. Designs patient profiles and writes medical monitoring plans in collaboration with the study medical monitor. Coordinates with clinical development to contribute to final study protocols, informed consent and study documents. Contributes to the development of CRFs, edit checks, IVRS systems. Attends site initiation visits (SIVs) and helps to address site questions regarding product scientific background and protocol design. Cultivates and develops relationships with KOLs, scientific advisory board and study investigators. Contributes to medical or scientific advisory boards, including development of materials, planning and execution as directed by the study medical monitor. Assists and reviews briefing books, requests for information, IND submissions, IND annual reports, Investigator Brochures, IMPD, BLA/NDA and other regulatory agency documents. Education & Professional Experience

Required: BS/BA degree in a scientific discipline is required and 7 years drug development experience or MS in scientific discipline and 6 years drug development experience and a post graduate PhD or Pharmacy degree is a plus. Direct experience in clinical scientist role, on a hematology/oncology program, and on global phase 2 or phase 3 pivotal studies. Experience with Microsoft Office (Excel, Word, PowerPoint) and ideally with medical review programs such as J-Review, Medidata Rave or similar databases. Flexible and adaptable to new priorities, and willing to work across different projects to provide support and scientific advice according to business needs. Driven, results-oriented self-starter and excellent team player. Creative and pragmatic approach to problem solving and issue resolution. Strong understanding of ICH GCP, and general biotechnology/pharma operating procedures and practices. Demonstrated excellent verbal, written, and interpersonal skills. Demonstrated experience leading and contributing through influence and working in cross functional teams. Working Conditions:

Busy office/virtual environment with frequent deadlines and interruptions. Travel:

Approximately 5-10% for site visits, advisory panels, medical and scientific conferences, and corporate events. Physical Requirements:

Subject to periods of sitting or standing, vision is required to monitor data.

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